- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05063773
Novel Wireless Mixed Reality Headset for Image Guidance in Cardiac Catheterization Laboratory (MRCCL)
September 21, 2021 updated by: SG Devices LLC
Our hypothesis is that improved line of sight to patient data, ergonomics, and headset lead shielding in the CCL will lead to behavioral changes in the CCL personnel that will reduce radiation exposure to all members of the team.
Further, reducing the burden of large, cumbersome monitors will enable improved use of shielding.
Our approach is a single center randomized controlled trial of consecutive patients randomly assigned to one of two groups with group 1 using mixed reality display and group 2 using standard 2D displays to perform diagnostic angiography in the CCL.
Radiation exposure will be evaluated at multiple levels including total radiation exposure, exposure of each individual staff member, as well as specific exposure to eyes and head in group 1 versus group 2.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- undergoing diagnostic coronary angiography
Exclusion Criteria:
- acute coronary syndrome, cardiogenic shock, cardiac arrest, planned intervention
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group 1
|
Physician will use a mixed reality headset for image guidance of the procedure
|
NO_INTERVENTION: Group 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Radiation exposure to the physician
Time Frame: up to 24 months
|
up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
radiation exposure to the patient and medical staff
Time Frame: up to 24 months
|
up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
March 1, 2023
Primary Completion (ANTICIPATED)
March 1, 2024
Study Completion (ANTICIPATED)
March 1, 2024
Study Registration Dates
First Submitted
September 8, 2021
First Submitted That Met QC Criteria
September 21, 2021
First Posted (ACTUAL)
October 1, 2021
Study Record Updates
Last Update Posted (ACTUAL)
October 1, 2021
Last Update Submitted That Met QC Criteria
September 21, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUD_002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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